Additional Relevant Details This change will add to the time and cost to complete the PERSIST trial, but the Company believes that a positive outcome from this trial design would result in a stronger NDA filing and potentially provide commercial advantages. The Company will provide an update on the impact to PERSIST once it has worked through the logistics of making this change. In the interim, the Company will continue enrollment under the existing protocol. As a point of reference, the Company notes that in cohort 2 of the BESST trial, which like PERSIST was in laparoscopic cholecystectomy patients, the control arm was also standard bupivacaine HCl and POSIMIR achieved a statistically significant pain reduction over 72 hours compared to the control when using the same statistical method being used in PERSIST.